The field of the invention pertains to medical appliances and, in particular, to devices that can be attached to the exterior skin of a person about or in an opening with the purpose of accepting and containing any solid or liquid material flowing from the opening. Such devices require a means of attachment that does not damage the skin but is reasonably secure.
Lognion, U.S. Pat. No. 4,496,356, discloses an anal excretion collection rectal catheter that is insertable beneath the sphincter muscles about the opening. The Lognion device comprises a collecting tube open at one end with a resilient ring that fits within the rectal opening.
Wade, U.S. Pat. No. 2,564,773, discloses a therapeutic agent comprising a thimble and latex bag insertable into a bodily opening for the collection of fluids. The bag folds within the thimble before use and may be attached to the thimble with an adhesive. The thimble includes an opening for the admission of fluids and is directly insertable into the bodily opening.
Wayne, U.S. Pat. No. 2,448,938 and Swiss Patent No. 113 453 each disclose a sanitary protective appliance of similar structure to receive bodily fluids and semi-solids from infections and incisions. The appliances comprise soft thin rubber tubes of accordion like shape with an opening of relatively large diameter. On the inside surface adjacent the opening is an adhesive ring to enable the device to be adhesively attached to the skin about the body opening from which there is a discharge.
Chen et al., U.S. Pat. No. 4,253,460 and Allen, Jr. et al., U.S. Pat. No. 4,650,817 both disclose adhesives suitable for attaching appliances such as ostomy devices to the skin about a body opening. Such adhesives must be secure, reasonably fluid tight but nevertheless easy to remove without damage to the skin.
U.S. Pat. No. 3,522,807 discloses an incontinence bag that has a pleated arrangement about the anus to expand and contract with the opening and closing of the anus. The overlapping leaves of the pleats do not provide for complete adhesive attachment to the skin thus permitting leakage and providing a difficult attachment.
U.S. Pat. No. 4,445,898 discloses a foam backed skin barrier attachment and incontinence bag. The skin barrier is disclosed as soft, pliable, stretchable and contractible foam backed plastic 0.080 to 0.400 inches thick. Plastic backed by foam has limited stretchability of less than 25% which limits the expandability of the anal hole in the skin barrier to an amount less than needed for most patients. In such cases, the anus can not open sufficiently, thereby causing severe pain, or the adhesive fails and the bag detaches and leaks.
Devices insertable within body openings have been found to cause permanent damage to the sphincter muscles after prolonged use. With a view toward overcoming and avoiding damage to the sphincter muscles of the anal opening but nevertheless providing a secure receptacle for bodily waste that does not damage the skin surrounding the anus, is sufficiently elastic (an elastic limit of about 200% or more) to accommodate the full opening of the anus and is easy to install, the herein named inventor developed the incontinence devices and applicators disclosed in U.S. Pat. No. 4,850,986 and PCT/US89/019601.
The devices disclosed therein have proven to overcome the disadvantages of the prior art noted above in that they provide an incontinence bag for holding body fluids which may be securably attached to, for example, the anus of a fecally incontinent person by means of the applicator disclosed therein. The bag remains securely attached during use, and attachment and removal are relatively simple. However, many fecally incontinent persons have hemorrhoids or other pathological conditions which limit the usefulness of the incontinence device. It is too uncomfortable to the user to adhere anything to hemorrhoidal tissue, which is unusually sensitive. Therefore, a bag with a larger hole must be used so that the bag may be attached to the tissue around the hemorrhoidal tissue. However, my previously disclosed applicators are primarily used to attach a bag having a standard size hole directly onto the skin overlying the anal sphincter.